The Norwegian biotech Zelluna has chosen Medpace to support the first clinical trial of ZI-MA4-1 (ZIMA-101), Zelluna's lead product candidate.
The new clinical partnership will involve Medpace providing its CRO services to support Zelluna's transition to a clinical-stage company and follows the submission of the Clinical Trial Application (CTA) to the MHRA.
ZI-MA4-1 is a novel cell therapy that combines two mechanisms to fight cancer.
The therapy brings together precise tumour recognition via T cell receptors (TCRs) that identify MAGE-A4, a protein found in many solid cancers and broad killing ability from Natural Killer (NK) cells that can eliminate cancer cells through multiple pathways simultaneously.
The Phase I study will evaluate the safety and early efficacy of ZIMA-101 in patients with advanced solid cancers, with data expected from mid-2026.
The trial also marks the first clinical evaluation of Zelluna's proprietary TCR-NK platform, a novel, allogeneic cell therapy platform that combines the high-precision targeting of TCRs with the cancer-killing ability of NK cells to treat solid tumours.
The partnership with Medpace marks a critical step in Zelluna's transition from preclinical to clinical stage. The CRO will provide comprehensive clinical development services, including clinical operations and trial management, regulatory support, data management and analysis, as well as pharmacovigilance.
This gives Zelluna access to experienced infrastructure and expertise necessary to execute a complex cell therapy trial in accordance with international standards.
"Selecting Medpace as our clinical partner reflects a deliberate and strategic choice as we transition into the clinical stage," said Namir Hassan, CEO of Zelluna.
"Medpace brings deep oncology expertise and a strong track record in early-phase development, including cell therapies."
"This first study will not only advance ZI-MA4-1, but also provide us with clinical insights into the broader potential of our TCR-NK platform."
"Zelluna's TCR-NK platform represents a novel and innovative approach to addressing key challenges in cell therapy for solid tumours," said Dr Lyon Gleich, Senior Vice President, Medical Department at Medpace.
"We look forward to partnering with the Zelluna team to support the efficient and rigorous execution of the ZI-MA4-1 first-in-human study."
Zelluna plans to initiate the first clinical trial of ZI-MA4-1, subject to regulatory approval (CTA approval), marking a key milestone in the clinical development of the company's off-the-shelf TCR-NK cell therapy portfolio.